N6264519RCES033-Attachment_V-_JA-Lab_Analyzer-Hologic-SD_Redacted.pdf

LOG# 19-10009

N6264519RCES033

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JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD on behalf of Naval Medical Center San Diego to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for a cost-per-test (CPT) contract for one (1) analyzer, laboratory, molecular assay, infectious microorganism [20-802], reagents, quality control, maintenance, and consumables for NMCSD. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Hologic, Inc. of 250 Campus Drive, Marlborough, MA 01752.

3. Description of the supplies/services required.

The Naval Medical Logistics Command has a requirement for a cost-per-test (CPT) contract for one (1) analyzer, laboratory, molecular assay, infectious microorganism [20-802], reagents, quality control, maintenance, and consumables for Naval Medical Center San Diego (NMCSD). The analyzer shall be an automated analyzer capable of analyzing nucleic acids from urine and swab samples to test for bacteria and DNA/rRNA/mRNA that causes sexually transmitted infections, including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Trichomonas vaginalis (TV), and Human Papillomavirus (HPV).

The analyzer unit shall be capable of handling a daily throughput of the following quantities:

Test Qty.

CT 250

GC 250

TV 10

HPV 80

HPV 16/18 10

a) The analyzer unit shall be a fully automated, random access robotic system.

b) The analyzer unit shall be capable of analyzing nucleic acids from male and female urine samples, endocervical samples, vaginal samples, and male urethral swabs.

c) The analyzer unit shall utilize Food and Drug Administration (FDA)-approved tests to test for CT, GC, TV, and HPV.

d) The analyzer unit shall be capable of conducting FDA-approved assays for HPV Genotype 16 and HPV Genotype 18.

e) The analyzer unit shall be FDA-approved for testing female gynecological specimens collected in ThinPrep Pap Test vials containing PreservCyst solution.

f) The analyzer unit shall be capable of simultaneously testing for the presence of CT, GC, TV, and HPV in the same sample.

g) The analyzer unit shall utilize nucleic acid amplification testing (NAAT) technology to perform simultaneous amplification and detection of target DNA or rRNA for CT, GC, TV, and E6/E7 mRNA for

HPV.

h) The analyzer shall be a single platform able to sample directly from patient collection tubes without removing caps, able to automatically dispense all reagents, and able to perform all automated steps for NAAT.

i) The analyzer shall be capable of performing the following procedures: sample preparation, separation suspension, reagent preparation, hybridization, separation, and detection.

j) Specimen flow from start to finish shall be fully-automated to include waste collection.

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k) The analyzer shall be able to read Code 39 barcodes.

l) The analyzer shall be capable of specimen storage stability of at least seven (7) days in a transport container for urine and swab samples stored at a minimum range of 2ºC to 30ºC.

m) Samples shall be able to be kept at -20ºC for up to 90 days if the time of transport/storage exceeds 30 days.

n) The analyzer unit shall have integrated software that allows for on-board maintenance/error code generation and automated troubleshooting procedures.

o) The software shall document procedures.

p) The analyzer unit shall bi-directionally interface with the Composite Health Care System (CHCS) and with the laboratory information system (LIS). If the vendor is not already approved to connect to CHCS bi-directionally, the vendor shall agree to complete any bi-directional interface integration at no additional cost to the Government. Interface integration must be completed prior to final acceptance of the system.

q) The analyzer unit shall meet the performance characteristics for accuracy, safety, and precision, as defined by the 1988 Clinical Laboratory Improvement Act (CLIA).

r) The units shall include an uninterruptable power supply (UPS) capable of providing all necessary electrical power to each analyzer.

s) The power requirements is 120 V, 60Hz.

The vendor shall provide installation, validation testing, user training, and preventive maintenance coverage. The vendor shall provide validation of the analyzers, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies, and establishment of initial control ranges using control materials.

Corrective system maintenance coverage shall occur Monday through Friday from 0730-1700 local time, excluding Federal Government holidays as seen at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay. This includes annually required preventive maintenance. Customer and Technical support should be available by phone 24 hours, 7 days a week. Training shall be provided by the vendor. The vendor shall provide two (2) operational and two (2) service manuals, each in English. Support shall be provided for a period of performance from 01 October 2019 to 30 September 2020, with four (4) subsequent one-year option periods.

The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with the Occupational Safety and Health Administration (OSHA) requirements.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations.

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4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1) and FAR 13.501(a), Only One Responsible Source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Only Hologic, Inc. can provide a CPT contract for anautomated infectious microorganism analyzer that is FDA-approved to test patient samples for CT, GC, TV, and HPV. No other vendor can provide an automated analyzer that is FDA-approved to test patient samples for all four (4) sexually transmitted infections specified in the minimum requirements. Hologic does not have any distributors. Only Hologic, Inc. can meet the minimum requirements of the Government.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the NECO and/or Federal Business Opportunities (FBO) in accordance with FAR 5.201. A Request for Information (RFI) was posted from 06 March 2019 to 11 March 2019 to FBO followed by a Notice of Intent (NOI) from 11 March 2019 to 26 March 2019. An email from PCR Biosystems Inc. was received from the RFI but it did not contain a capability statement and no further information was provided to the NOI expressing an interest in the requirement moving forward.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in February 2019. Research included references and information derived from Internet searches via Google, Defense Medical Logistics Standard Support (DMLSS), FDA 510(k), and the ECRI Sourcebook. It was determined that infectious microorganism analyzers that can test patient samples for bacteria and/or DNA/rRNA/mRNA that cause sexually transmitted infections can be provided by the following vendors: Abbott Laboratories (Abbott), Becton, Dickinson and Company (BD), BioMérieux, Inc., Cepheid, Hologic, Inc., Qiagen, Inc., and Roche Diagnostics Corp. (Roche).

Abbott, Qiagen, and Roche can provide automated infectious microorganism analyzers that can test for CT, GC, and HPV but the analyzers cannot test patient samples for the presence of TV. Therefore, Abbott, Qiagen, and Roche cannot meet the minimum requirements of the Government. BD can provide three (3) automated infectious microorganism analyzers: BD MAX CT/GC/TV, BD Viper with XTR Technology, and BD Viper LT. BD Max CT/GC/TV and BD Viper with XTR Technology can test patient samples for the presence of CT, GC, and TV but they cannot test for the presence of HPV mRNA.

BD’s HPV assay is only FDA-approved for use with the BD Viper LT. The BD Viper LT can test for the presence of CT, GC, and HPV in patient samples but the analyzer cannot test for the presence of TV.

BioMérieux can provide an analyzer that tests for HPV, but it cannot test for the presence of CT, GC, or

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TV. Cepheid has an analyzer that can test for the presence CT, GC, and TV in patient samples but the analyzer is not yet FDA-approved for HPV testing. Therefore, BD, BioMérieux, and Cepheid cannot meet the minimum requirements of the Government. Only Hologic can provide a CPT contract for an automated infection microorganism molecular assay laboratory analyzer that is FDA-approved to test for CT, GC, TV, and HPV in patient samples. Therefore, only Hologic can meet the minimum requirements of the Government. It is noted that the previous contract was awarded via a sole source to Gen Probe, Inc. Hologic has acquired Gen-Probe, Inc. since previous contract was executed.

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FBO in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

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TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical/Requirements Cognizance

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and find this J & A to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($700,000-$12.5M)